Columbia University Irving Medical Center
New York, 10032, United States
Location status: Recruiting
Location contact
Aleha Aziz, MD, MPH
CONTACT
Aleha Aziz, MD, MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT03667326
The purpose of this research study is to find out whether women with severe preeclampsia taking low-dose aspirin (LDA) for 3 weeks post-delivery will experience an improvement in endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as the effects of preeclampsia can persist postpartum. Women diagnosed with severe preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 3 weeks post-delivery. Exploratory objective includes healthy control postpartum patients without preeclampsia and not on LDA during pregnancy or postpartum in comparison with the primary study population affected by preeclampsia with severe features.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 2
New York, 10032, United States
Location status: Recruiting
Aleha Aziz, MD, MPH
CONTACT
Aleha Aziz, MD, MPH
PRINCIPAL_INVESTIGATOR
Preeclampsia is a serious disease of pregnancy that manifests with increased blood pressure and can affect all the organs in a woman's body. It usually develops after 20 weeks of pregnancy. There is an abnormal amount of protein in the urine and with worsening disease known as "severe features," patients can have pain in the upper abdomen, changes in vision, fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal liver or kidney function. Very high blood pressure is also considered a severe feature. The exact cause of preeclampsia is unknown but women with the condition are at increased risk for complications during pregnancy, including seizures - eclampsia. Babies are at risk of being born premature because the only cure for preeclampsia is delivery. Women who have had preeclampsia are also at increased risk of cardiovascular and kidney disease later in life, including heart attack, stroke and high blood pressure. Studies show that women at high risk for preeclampsia, i.e., have had preeclampsia in a prior pregnancy, are carrying more than one fetus, have a history of high blood pressure, kidney disease or both, have certain medical problems such as diabetes, thrombophilia or lupus, have a modestly decreased risk of disease with daily intake of low-dose aspirin starting after 12 weeks of pregnancy.
Due to the limited data available on the topic of LDA in preeclamptic patients in the postpartum period, particularly as applicable to the American population, the investigator intends to start with a small pilot study involving the collection of information on 10 women not exposed to study intervention. This will allow for confirmation of the sample size based on the baseline FMD measurements 2 days after delivery.
Investigator will also explore a small sub-study to gather information regarding baseline FMD and biomarker values for healthy control postpartum patients, unaffected by preeclampsia and not on LDA during pregnancy or postpartum.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For sub-study patients, inclusion and exclusion criteria will be the same, with the exception of diagnosis of severe preeclampsia prior to delivery (exclusion criterion for healthy controls group).
Low dose aspirin, 81mg tablets, PO
Other names: Aspirin
Placebo oral capsule, PO
Other names: Placebo
Time frame: Up to 3 weeks postpartum
This is designed to measure if patients with preeclampsia with severe features diagnosed antepartum or intrapartum, will experience an increase in Flow-Mediated Dilation (FMD) - a measure of endothelial function - within 3 weeks after delivery when taking daily LDA in the postpartum period.
Time frame: Within 3 weeks postpartum
This is to measure if patients will experience a decrease in systolic blood pressure (SBP) within 3 weeks after delivery when taking daily LDA in the postpartum period.
Time frame: Within 3 weeks postpartum
This is to measure if patients will experience a decrease in diastolic blood pressure (DBP) within 3 weeks after delivery when taking daily LDA in the postpartum period.
Time frame: Up to 3 weeks postpartum
This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period.
Time frame: Up to 3 weeks postpartum
This is to measure if patients will experience a decreased likelihood of receiving magnesium sulfate postpartum again when taking daily LDA in the postpartum period?
Time frame: Up to 3 weeks postpartum
This is to measure if patients will experience a decreased rate in initiation of/ increase in/ addition of blood pressure medication postpartum when taking daily LDA in the postpartum period.
Time frame: Up to 3 weeks postpartum
This is to measure if patients will experience a decreased rate of hospital readmissions for postpartum preeclampsia when taking daily LDA in the postpartum period.
Contact information is provided by the study sponsor or research team.
Columbia University
Other
Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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